GM Food Legislation in the European Union

Summary

Note: This page considers the EU legislation on genetically modified (GM) foods. Originally the controls were based on those applied to 'novel foods'. However in 2003 separate EU legislation was adopted on GM food. For details of legislation on 'novel foods', see the other page: Novel Food Legislation in the EU. The following diagram illustrates the development of both the GM controls and those for 'novel foods':

Initial controls for the approval and use of genetically modified materials in agriculture were established by Directive 90/220 on the deliberate release into the environment of genetically modified organisms. These were subsequently updated and replaced by Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC.

The use of GM material for food was initially covered by Regulation 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients which came into effect on the 15 May 1997 - foods used before this date would not be considered 'novel'. This contained provisions for the approval of GM material as food and for the possible requirement for labelling. However, before May 1997 two GM products (one soya and one maize) had been approved for use under Directive 90/220 and could not therefore be subject to the rquirements of Regulation 258/97 (since, by definition, they could not be considered 'novel'). Special controls were therefore adopted by Regulation 1813/97 to impose the same requirements for labelling on these two GM products as would have been required under the novel food controls. Howver as imports were just beginning to arrive, consumer concerns increased and additional special labelling rules were introduced, first by Regulation 1139/98 and then by Regulation 49/2000.

Major changes were introduced in 2003 with the adoption of specific controls applying to both food and feed - Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. This removed GM food from the definition of 'novel food' and contained updated procedures for the approval of GM food and for the labelling of products derived from GM material.

Approval of GM material for food use has been controversial and Member States are divided on whether they should be used for food. Although the European Food Safety Authority has generally issued positive opinions on their safety (itself also controversial), Member States have subsequently failed to agree and adopt the necessary legal documents. Regulation 1829/2003 (and related procedural regulations) allows the Commission to adopt the approval if Member States fail to reach agreement within specified time limits and this has been the route for the adoption of most approvals. Similar issues have arisen under Directive 2001/18 but an amendment (by Directive 2015/412) allows Member States to restrict use in agriculture on their territory. To try and resolve the problem for food and feed, the Commission proposed (in COM(2015)177) a similar amendment to Regulation 1829/2003 allowing Member States to prohibit (under specified conditions) the use of approved GM foods in their territory. This though was rejected by the European Parliament; as the Commission did not withdraw the proposal, it is officially still awaiting the Council to reach a position at first readiing.

EU Legislation

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
(OJ L106, 17.4.2001, page 1) See also: Commission Declaration(OJ L106, 17.4.2001, page 39)

Amendments:

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L268, 18.10.2003, page 1)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
(OJ L268, 18.10.2003, page 24)

Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission

Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L68, 13.3.2015, page 1)

Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms (OJ L67, 9.3.2018, page 30)

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
(OJ L268, 18.10.2003, page 1)

Amendments:

Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms (OJ L368, 23.12.2006, page 99)

Regulation (EC) No 298/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 1829/2003 on genetically modified food and feed, as regards the implementing powers conferred on the Commission (OJ L97, 9.4.2008, page 64)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
(OJ L268, 18.10.2003, page 24)

Amendment:

Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part One (OJ L311, 21.11.2008, page 1)

COM/2015/0177 - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory